Phase II Trial of Transdermal Estradiol for Hormone Refractory Prostate Cancer

Inclusion Criteria

• •Patients with metastatic prostate adenocarcinoma, who have failed initial hormone therapy and who have had progression after at least one chemotherapy regimen that included docetaxel. Patients on antiandrogens must have progression after withdrawal of the antiandrogen for 4 weeks (flutamide) or 6 weeks (bicalutamide).
• •PSA ≥ 10 ng/ml.
• •Patients who have received LHRH agonist therapy for \> 1 month must maintain agonist therapy while on-study. Patients who have not received agonist therapy or received \< 1 month of therapy, may not begin or continue agonist therapy while on-study.
• •Age \>18 years and an estimated life expectancy of at least 4 months.
• •ECOG performance status ≤ 2 (see Appendix B).
• •Full recovery from the effects of any prior surgery or radiation therapy within 4 weeks of study entry.
• •Serum creatinine ≤ 1.5 x ULN
• •Total bilirubin \< ULN
• •Transaminases (SGOT and/or SGPT) ≤ 2 X institutional upper limit.
• •Capacity to give informed, written consent.